Phase II, multicentre, double blind, placebo controlled, parallel group, dose ranging study of ATL-962 (cetilistat) to assess weight loss, safety and tolerability in obese patients with Type II diabetes being treated with metformin, in comparison with orlistat
| ISRCTN | ISRCTN62647464 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62647464 |
| Secondary identifying numbers | ATL-962/175/CL, orlistat |
- Submission date
- 05/09/2005
- Registration date
- 16/09/2005
- Last edited
- 14/10/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Peter Kopelman
Scientific
Scientific
Barts and The London
Queen Mary's School of Medicine & Dentistry
30-32 Newark Street
London
E1 2AA
United Kingdom
Study information
| Study design | Randomised three arm placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | Does ATL-962 induce weight loss in diabetic patients and is its safety and tolerability profile superior to that of orlistat in such patients? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obesity in patients with Type II diabetes |
| Intervention | ATL-962 (40 mg, 80 mg, or 120 mg), or placebo, or orlistat (120 mg) three times a day for 12 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | ATL-962 (cetilistat), orlistat, metformin |
| Primary outcome measure | Absolute weight loss compared to baseline |
| Secondary outcome measures | Proportion of patients achieving 5% or 10% weight loss; changes in waist circumference; changes in lipid profiles; changes in markers of diabetes; incidence of GI adverse events; changes in other safety parameters |
| Overall study start date | 01/12/2004 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Not Specified |
| Target number of participants | 600 patients randomised |
| Key inclusion criteria | 1. Type II diabetic patients 2. Aged 18-65 3. Body Mass Index (BMI) between 28 kg/m2 and 45 kg/m2 4. Glycosylated haemaglobin (HbA1c) value between 6% and 10% 5. Being treated with a stable dose of metformin |
| Key exclusion criteria | 1. Significant weight loss in the previous 3 months 2. Weight gain during the run-in period 3. Other serious systemic disease, except for controlled hypertension, mild asthma, and primary hypothyroidism 4. History of GI disorders 5. Previous surgery for weight loss |
| Date of first enrolment | 01/12/2004 |
| Date of final enrolment | 30/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Barts and The London
London
E1 2AA
United Kingdom
E1 2AA
United Kingdom
Sponsor information
Alizyme (UK)
Industry
Industry
Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
| Phone | +44 (0)1223 896 000 |
|---|---|
| Medical.Information@alizyme.co.uk | |
| Website | http://www.alizyme.com |
Funders
Funder type
Industry
Alizyme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2010 | Yes | No |
